Heart Valve Diseases
Conditions
Brief summary
The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart valve repair.
Interventions
DRUGAtorvastatin
Sponsors
Urmia University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than 25 y/o * No occurrence of intra- or post-operative cardiopulmonary arrest * Not consuming drugs affecting atrial rhythm * Having sinus rhythm before surgery * Lack of paroxysmal atrial fibrillation history * Only undergo heart valve surgery * Lack of considerable heart ischemia needed atorvastatin use * Routine cares in ward, post-operative ward, and intensive care unit were done
Exclusion criteria
* Lesser than 25 y/o * History of atrial fibrillation * History of taking anti-arrhythmic drugs * History of implementing pacemakers * Severe heart failure * Renal failure * Hepatic failure * Severe pulmonary diseases * Heart block or bradyarrhythmia * Routine cares in ward, post-operative ward, and intensive care unit were not done * Performing concomitant cardiac surgery except valve repair * Having considerable heart ischemia needed atorvastatin use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial Fibrillation Incidence After Open Cardiac Valve Repair | Within 5 days after open cardiac valve repair |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery | 29 |
| Control Placebo | 29 |
| Total | 58 |
Baseline characteristics
| Characteristic | Treatment | Control | Total |
|---|---|---|---|
| Age, Continuous | 54 years | 45 years | 49 years |
| Region of Enrollment Iran, Islamic Republic of | 29 participants | 29 participants | 58 participants |
| Sex: Female, Male Female | 21 Participants | 18 Participants | 39 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 1 / 29 | 2 / 29 |
Outcome results
Primary
Atrial Fibrillation Incidence After Open Cardiac Valve Repair
Time frame: Within 5 days after open cardiac valve repair
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Atrial Fibrillation Incidence After Open Cardiac Valve Repair | 6 participants |
| Control | Atrial Fibrillation Incidence After Open Cardiac Valve Repair | 13 participants |